NCT02284165

Brief Summary

Retrospective analysis of Get With the Guidelines-Stroke data linked with Medicare claims and the AVAIL longitudinal data sets to assess patterns, predictors, and outcomes associated with the use of rehabilitation services following hospitalization for ischemic stroke. Primary completion defined as the end of primary analyses, consistent with the end of the PCORI Cycle I grant period. Study completion defined as acceptance of final research report and lay abstract by PCORI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164,246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 9, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

November 3, 2014

Results QC Date

July 7, 2016

Last Update Submit

February 1, 2018

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services

    Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.

    discharge through 90 days

  • Home-time

    Number of days alive and living outside of inpatient care

    12 months post-discharge

Secondary Outcomes (5)

  • Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge

    12 months post-discharge

  • Quality of Life (QOL)

    12 months post-discharge

  • Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.

    12 months post-discharge

  • Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.

    12 months post-discharge

  • Number of Participants Who Died Within 12 Months of Stroke Hospitalization

    12 months post-discharge

Interventions

retrospective analysisOTHER

Analysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized for acute ischemic stroke in 2006-2008, and successfully linked to Medicare claims available through 2009

You may qualify if:

  • acute ischemic stroke within the Get With the Guidelines-Stroke data set for 2006-2008, and successfully linked to Medicare claims through 2009

You may not qualify if:

  • death during index hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

  • Xian Y, Thomas L, Liang L, Federspiel JJ, Webb LE, Bushnell CD, Duncan PW, Schwamm LH, Stein J, Fonarow GC, Hoenig H, Montalvo C, George MG, Lutz BJ, Peterson ED, Bettger JP. Unexplained Variation for Hospitals' Use of Inpatient Rehabilitation and Skilled Nursing Facilities After an Acute Ischemic Stroke. Stroke. 2017 Oct;48(10):2836-2842. doi: 10.1161/STROKEAHA.117.016904. Epub 2017 Aug 22.

    PMID: 28830975DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Janet Prvu Bettger, ScD
Organization
Duke Clinical Resarch Institute
janet.bettger@duke.edu
617-901-0277

Study Officials

  • Janet Bettger, ScD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 5, 2014

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 1, 2018

Results First Posted

January 9, 2017

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)